Date of Award
2010
Document Type
Thesis
First Advisor
William Lahey
Second Advisor
Jocelyn Downie
Abstract
This thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion of the proposed Progressive Licensing model, and Bill C-51-An Act to Amend the Food and Drug Act, raises the concerns with a shift to a system largely based on risk assessment and post-market monitoring (pharmacovigilence).
Recommended Citation
Michael Duncan Taylor, A Bitter Pill to Swallow: Canadian Drug Regulation (LLM Thesis, Dalhousie University, 2010) [unpublished].
